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A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors

StatusCompleted
PhasePhase 1
Started
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Record History

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  1. Primary endpoint(s) modified Show 9 more changesShow less
    • Phase changed: Phase 1/2 → Phase 1
    • Trial completed
    • Final enrollment: 27 participants (planned 100)
    • Primary completion date changed from estimate of Apr 2027 to Jul 8, 2026
    • Trial arms changed: 2 → 1
    • Eligibility criteria shortened, about 30 words
    • Secondary endpoints: 8 to 4
    • Study description expanded, about 45 words
    • Site details revised at 1 of 9 sites
  2. Enrollment closed, study ongoing
    • Site details revised at 9 of 9 sites
    v7
  3. Secondary endpoints: 7 to 8
    • Site details revised at 2 of 9 sites
    v6
  4. Primary endpoints: 5 to 4
    • Study sites: 7 to 9
    • Secondary endpoints: details revised at 2 of 7 entries
    • Eligibility criteria expanded, about 3 words
    v5
  5. Study sites: 6 to 7v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 3 to 6v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of May 2024 to Jun 18, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Apollo Therapeutics Ltd
5 trials monitored
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Breast Cancer
5,418 trials monitored
See 296 trials at risk
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
Prostate Cancer
2,546 trials monitored
See 172 trials at risk
and 6 more diseases
This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-5125 for the treatment of selected locally advanced or metastatic solid tumors with particular focus on Colorectal carcinoma (CRC).
Trial Details
NCT Number NCT06399757
Lead Sponsor Apollo Therapeutics Ltd
Conditions
(from sponsor)		 Colorectal Cancer, Cholangiocarcinoma, Appendiceal Adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Endometrial Adenocarcinoma, Triple Negative Breast Cancer, Ovarian Cancer +1 more
Related terms Adenocarcinoma, Mucinous, Cholangiocarcinoma, Colorectal Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Triple Negative Breast Neoplasms
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov